Biotech Stocks Facing FDA Decision In March 2026

(RTTNews) - As we head into the final month of the first quarter, it's time to take stock of the regulatory landscape. But before we turn to the upcoming FDA decisions, here are some of the regulatory developments that made headlines in February.

On Feb.10, 2026, the FDA launched a comprehensive re-assessment of Butylated hydroxyanisole to consider whether it remains safe under its current conditions of use in food and as a food contact substance, based on the latest scientific information.

Butylated hydroxyanisole (BHA) has long been used as a chemical preservative to prevent the spoilage of fats and oils. It is commonly found in a variety of food products, including frozen meals, breakfast cereals, cookies, candy, ice cream, and processed meats. Although animal studies have identified BHA as a potential human carcinogen, it has remained in the food supply.

On February 12, 2026, the FDA approved labeling updates for six menopausal hormone therapy products, also referred to as hormone replacement therapy (HRT), including Prometrium, Divigel, Cenestin, Enjuvia, Estring, and Bijuvato. The updates clarify risk considerations and remove boxed warnings related to cardiovascular disease, breast cancer, and probable dementia.

The same day, the FDA approved Novocure's Optune Pax, a first-of-its-kind device for the treatment of adult patients with locally advanced pancreatic cancer.

Now, let's take a look at the biotech stocks facing FDA decision in March 2026.